UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study of paclitaxel with Bevacizumab for advanced or recurrent breast cancer(SBCCSG-28)
Title of the study (Brief title)	Observational study of paclitaxel with Bevacizumab for advanced or recurrent breast cancer(SBCCSG-28)
Region	Japan

Condition
Condition	advanced or recurrent breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the time to treatment failure and safty of Paclitaxel with Bevacizumab for advanced or recurrent breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	time to treatment failure
Key secondary outcomes	overall survival

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1.Treatment with Bevacizumab planned case 1-1.Histologically diagnosed with uniateral primary or recurrent breast cancer 1-2.>=20years old 1-3.No previous treatment with Bevacizumab 1-4.If hospital need written informed consent,is taken 2.In treatment with Bevacizumab case 2-1.Histologically diagnosed with uniateral primary or recurrent breast cancer 2-2.>=20years old 2-3.During treatment with Bevacizumab 2-4.If hospital need written informed consent,is taken 3.After treatment with Bevacizumab case 3-1.Histologically diagnosed with uniateral primary or recurrent breast cancer 3-2.>=20years old 3-3.Afer treatment with Bevacizumab 3-4.If hospital need written informed consent,is taken
Key exclusion criteria	Only treatment with Bevacizumab planned case 4-1.Have hypersensitivity to Bevacizumab 4-2.During pregnancy or lactation 4-3.Patients receiving anticoagulant therapy 4-4.Daily treatment with hight-dose aspirin(>=325mg/day) or non-steroidal anti-inflammatory medications for chronic inflammatory disease 4-5.Bleeding tendency(including significant hemoptysis or pulmonary tumor cavitation and necrosis),(INR>=1.5 within two weeks prior to entry) 4-6.Uncontrolled peptic ucer 4-7.Perforation of gastrointestional tract within one year 4-8.Renal failure to treated,2+ or higher proteinuria within two weeks prior to entry 4-9.Uncontrolled hypertension 4-10.Clinically significant cardiovascular disease(>=Grade2 according to the Common Toxicity Criteria of the National Cancer Institute,version 4), clinically important echocardiographic findigs,or past or current history(within the last one year)of myocardial infarction 4-11.Not appropriate for the study at the physician's assessment
Target sample size	70

Research contact person
Name of lead principal investigator	Inoue Kenichi
Organization	Saitama Cancer Center
Division name	Breast Cancer Oncology
Address	818 Komuro Ina-machi Kitaadachi-gun Saitama 362-0806
TEL	048-722-1111
Email	ino@cancer-c.pref.saitama.jp

Public contact
Name of contact person	Toshihiro Kai
Organization	Saitama Breast Cancer Clinical Study Group (SBCCSG)
Division name	Secretariat Division (Shintoshin Ladies' MammoClinic)
Address	3F Capital building, 4-261-1 Kishiki-cho, Omiya-ku, Saitama-shi, 330-0843, Japan
TEL	048-600-1722
Homepage URL	http://www.sbccsg.org/
Email	toshikai@sbccsg.org

Sponsor
Institute	Saitama Breast Cancer Clinical Study Group (SBCCSG)
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	埼玉県立がんセンター（埼玉県），さいたま赤十字病院（埼玉県），埼玉社会保険病院（埼玉県），埼玉医大総合医療センター（埼玉県），自治医大さいたま医療センター（埼玉県）赤心堂病院（埼玉県），三井病院（埼玉県）

Other administrative information
Date of disclosure of the study information	2012 Year 10 Month 12 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 09 Month 30 Day
Anticipated trial start date	2012 Year 10 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To evaluate the time to treatment failure and safty of Paclitaxel with Bevacizumab for advanced or recurrent breast cancer

Management information
Registered date	2012 Year 10 Month 11 Day
Last modified on	2017 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010665